Kornimate/medical-research-clean huggingface dataset:
understanding value in metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: the overall objective of this project is to gain knowledge about out-of-pocket (oop) expenses and lost opportunity costs among metastatic breast cancer (mbc) patients. to achieve this objective, mbc patients will be asked to participate in a short, 37-question survey asking questions about the financial burden, oop expenses, and opportunity costs related to their cancer care

the treating physician, pi or study coordinator will inform eligible mbc patients about the study via a letter (appendix b) during or prior to their regular clinic visits in a waiting area. prior to the survey administration, study coordinator will obtain all necessary signatures on the icf from interested study participants in the private clinic room or infusion area. the survey (appendix a) will consist of 37 survey questions, which should take patients less than 30 minutes to complete during their regularly scheduled clinic visit. study participants will have the option of taking incomplete surveys home, completing, and mailing it back to us using stamped, self-addressed envelopes provided during their clinic visit. all consented participants will also be given the option to complete the survey over the phone with a study coordinator. participants will be requested to provide their preferable times and days for a phone call with a coordinator. the study coordinator will call the patient and administer the same survey that would be given during a clinic visit. if participants prefer completing the survey in the clinic a research coordinator will remain in the room and will verbally facilitate the completion of the survey. participants will be compensated in the form of merchandise at the time they agree to participate (the photo of sample merchandise is attached). surveys will be collected by the study coordinator and stored in secure, locked rooms at the uab comprehensive cancer center, where the study coordinators will double-key enter de-identified survey responses into an encrypted, password protected, electronic database.

Eligibility criteria:
inclusion criteria: * all female mbc patients 18 years of age and older who have received treatment within the past two years at uab exclusion criteria: * non-english speakers, patients residing in nursing homes or receiving hospice care

Keywords: financial burden out of pocket expenses time spent on healthcare metastatic breast cancer
immediate fracture risk after antihypertensive drug initiation

Conditions: Hypertension; Fracture

Summary: this retrospective observational study aims to evaluate the short-term fracture risk associated with anti-hypertensive medication initiation using a self-controlled case series (sccs) design and investigate temporal trends of initial anti-hypertensive regimen (monotherapy vs combination therapy) and subsequent fracture incidence. the investigators use the korean health insurance review and assessment (hira) database to identify adults aged ≥65 with a new prescription for anti-hypertensive therapy and at least one incident non-traumatic fracture. in the sccs analysis, the investigators estimate the within-person incidence rate of overall fractures during the 30-day period following anti-hypertensive initiation compared to control periods. temporal trends will be recorded through 2013 - 2022. the primary outcome is overall non-traumatic fracture occurrence; the secondary outcome is incident proximal hip fracture. these outcomes are defined using diagnostic and procedural codes validated for use in claims data. this study aims to quantify both the immediate temporal association between treatment initiation and fracture risk, and the comparative safety of different initial anti-hypertensive regimens.


Eligibility criteria:
inclusion criteria: * individuals with at least 365 days of continuous observation prior to the index date (defined as the date of first antihypertensive medication prescription), with no prior antihypertensive use during that period * at least one diagnosis of hypertension (icd-10 codes i10-i13, i15) recorded within 180 days before the index date exclusion criteria (main cohort): * any of the following occurring in the 365 days prior to the index date: hospitalization (inpatient admission, including long-term care facility), transport-related trauma (icd-10 codes v01-v99), intentional self-harm (icd-10 codes x60-x84, y87), history of pathological fractures (e.g., m84.4, m90.7), evidence of end-stage renal disease (esrd), dialysis, kidney transplant, renal osteodystrophy
exercise intervention for bone tumor patients

Conditions: Bone Sarcoma

Summary: the progait-study is a two-arm exercise intervention study for aya-patients with lower extremity tumor endoprosthesis in the follow-up care. this clinical trial will investigate the effects of an 8-week personalized multi-modal exercise intervention of lower extremity muscles on gait quality in adolescents and young adults with cancer diagnosis beginning at least 12 months after endoprosthesis implantation.

the main objective of the progait-study is to investigate the effects of an 8-week personalized, partially supervised exercise program for lower extremity muscles on gait kinematics of adolescents and young adults, who are in follow-up care after cancer treatment and at least 12 months after endoprosthesis implantation. this randomized controlled trial will include n=20-30 patients. patients will be randomly assigned to the intervention or control group. patients in the intervention group will perform two supervised exercise sessions in week one and two. in the following weeks, they will perform in a mix of supervised and unsupervised exercise sessions to introduce the patients into independent exercise. both groups receive recommendations for individual lower extremity exercise. secondary aims of this interventional study are to evaluate functional mobility, knee range of motion and patient-reported outcomes including qol and fatigue.

Eligibility criteria:
inclusion criteria: * adolescents and young adults between 15 and 45 years of age * completion of acute cancer treatment and receiving follow-up care in essen (university hospital essen) * at least 12 months post endoprosthesis implantation * signed informed consent (parents and patient) exclusion criteria: * \ 45 years of age * time post implantation \<12 months * medical condition that limits participation in one of the study arms * inability to follow the training-protocol

Keywords: exercise lower limb endoprosthesis pediatric oncology gait quality 3d gait analysis
evaluation of safety and immunogenicity of gsk biologicals' influenza vaccine gsk2186877a in adults 65 years and older

Conditions: Influenza

Summary: the purpose of this study is to evaluate the safety and immunogenicity of glaxosmithkline biologicals' influenza vaccine gsk2186877a in adults 65 year of age and older. this protocol posting deals with objectives \& outcome measures of the extension phase at year 1. the objectives \& outcome measures of the primary phase are presented in a separate protocol posting (nct number = 00540592).


Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that they can and will comply with the requirements of the protocol. * a male or female aged 18-41 years or ≥65 years at the time of the vaccination and who participated in the 110847 study and completed the 6 month follow-up. * written informed consent obtained from the subject. * fee of acute aggravation of the health status as established by clinical evaluation (medical history and medical history directed examination) before entering into the study. * female subjects must be of non-childbearing potential. exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to vaccination, or planned use during the study period. * administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. planned administration of an influenza vaccine other than the study vaccines or of a vaccine not foreseen in the study protocol during the entire study period. * vaccination against influenza since january 2008 with a seasonal influenza vaccine. * chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * history of hypersensivity to a previous dose of influenza vaccine. * history of allergy or reactions likely to be exacerbated by any component of the vaccine(s). * acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation (medical history and medical history directed physical examination) or pre-existing laboratory screening tests. * acute disease at the time of enrolment. * administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the study vaccine or planned administration during the study. * any medical conditions in which im injections are contraindicated. * lactating female, female planning to become pregnant or planning to discontinue contraceptive precautions.

Keywords: influenza elderly
retinal neurodegenerative and vascular changes in diabetic patients

Conditions: Diabetic Retinopathy; Neurodegeneration

Summary: using optical coherence tomography and imagej software the investigators will analyze retinal and choroidal vascular changes and their impact on retinal layers among patients with diabetes without retinopathy and patients with diabetes and retinopathy.

relieving the burden of diabetic retinopathy treatment require a prompt and non-invasive assessment of diabetic patients before the occurence of diabetic retinopathy. since oct is capable of imaging retina with such a high precision, retinal changes occuring before any clinical signs of retinopathy, such as microaneurysm or haemorrhages, can now be assessed. in the present study the investigators are analyzing the connection between retinal arteries and veins regarding lumen diameter, vessel wall thickness and their correlation with retinal nerve fiber layer and ganglion cell layer thickness. moreover, using binarization of the choroid the investigators will assess its relationship with outer retina layers, such as retinal pigment epithelium and photoreceptors.

Eligibility criteria:
inclusion criteria: * history of type 1dm for more than 1 year * history of type 2 dm for more than 3 months * diagnosis of no dr or mild non-proliferative diabetic retinopathy(npdr) exclusion criteria: * dr with more than npdr , * diabetic macular oedema, * media opacities such as corneal or lens opacities that could preclude appropriate oct imaging, * presence of other retinal diseases such as age-related macular degeneration, vitreo-macular traction, macular hole, epiretinal membrane, retinal vein occlusion, macular scars, * glaucoma, optic neuropathies or neurodegenerative diseases, * history of ocular trauma, * refractive errors of more than ±6 diopters (spherical equivalent), * previous ocular surgery, focal laser, panretinal photocoagulation or anti-vegf intravitreal injection

Keywords: optical coherence tomography choroid outer retina
effectiveness of a supervised multicomponent exercise-based telerehabilitation intervention on physical performance in older patients with multiple chronic conditions in colombia

Conditions: Non Communicable Chronic Diseases

Summary: currently, the older adult population faces an increase in the prevalence of cardiopulmonary diseases, which negatively impact their quality of life by limiting their ability to perform daily activities and affecting their physical and emotional well-being. in particular, cardiovascular and respiratory diseases are among the leading causes of morbidity and mortality among older adults in colombia. despite advances in pharmacological treatment and medical care, physical rehabilitation remains an essential component in the management of these diseases, with physical exercise serving as one of its fundamental pillars. however, access to physical rehabilitation programs for the older adult population, particularly in rural or hard-to-reach areas, continues to pose a significant challenge. telemedicine and information and communication technologies (ict) have emerged as viable solutions to overcome this barrier, enabling the remote prescription and monitoring of physical exercises, facilitating the inclusion of more patients in rehabilitation programs, and improving their quality of life. therefore, this study aims to evaluate the effectiveness of a multicomponent ict-mediated intervention in terms of improving physical condition, reducing frailty, adherence, satisfaction, and quality of life in older adults with cardiopulmonary diseases.


Eligibility criteria:
inclusion criteria * diagnosis of a non-communicable disease. * ability to communicate verbally or in writing. * stable disease status confirmed by clinical history. * condition present for at least three months to qualify as chronic. * for patients with type ii diabetes mellitus: glucose levels below 200 mg/dl during tele-rehabilitation sessions. exclusion criteria * requirement for assistance with walking. * history of disease exacerbation within the past six months.

Keywords: exercise therapy elderly telerehabilitation
post thrombotic syndrome prevention study

Conditions: Post Thrombotic Syndrome; Deep Vein Thrombosis

Summary: this is a two arm, prospective, single center, randomized clinical trial. subjects will be randomly assigned into one of two groups using block randomization technique in a 1:1 ratio. the control group will receive care using elastic compression stocking and the intervention group will use the actitouch device. stratified randomization will occur based on whether the deep vein thrombosis (dvt) has iliac or non-iliac involvement. subjects will be followed for 2 years with clinic visits occurring at 1, 3, 6, 12, and 24 months.

the purpose of this study is to determine if use of a pneumatic compression device (actitouch, tactile medical) is beneficial in improving or preventing the development of post thrombotic syndrome (pts). 84 patients who have a history of an acute proximal unilateral leg dvt diagnosed one or more months prior to enrollment, or diagnosed with a chronic proximal unilateral leg dvt at time of enrollment, on duplex or other imaging study will be randomized into two groups: the control group receiving the standard of care compression stockings and the intervention group receiving actitouch device.

Eligibility criteria:
inclusion criteria: * at least 18 years of age or older * history of an acute proximal unilateral leg dvt diagnosed one or more months prior to enrollment, or diagnosed with a chronic proximal unilateral leg dvt at time of enrollment, on duplex or other imaging study (i.e mrv, ctv, venogram) * current anticoagulation therapy * physical ability to independently don actitouch or availability of help to place device exclusion criteria: * current diagnosis of pts or pts symptoms * diagnosis of acute dvt less than 30 days prior to enrollment * history of prior ipsilateral dvt * chronic venous insufficiency (cvi) with a ceap 4 or greater and/or noted changes in the deep system during the diagnosing duplex * morbid obesity (bmi \> 45) * congestive heart failure with symptoms not controlled by medical intervention * pulmonary edema, active, with symptoms not controlled by medical intervention * peripheral artery disease (pad) unless the patient has an ankle pressure of 60mmhg or more * walking disability (immobile) * women who are pregnant or trying to become pregnant * any other condition in which compression would be contraindicated as determined by the treating physician

Keywords: adaptive compression therapy delivery system
pilot study of the ace system in lung procedures

Conditions: Lung Diseases

Summary: to evaluate the xact ace robotic system in lung procedures.

the xact ace robotic system is a user-controlled positioning system intended to assist in the planning and advancement of an instrument during computed tomography (ct) guided percutaneous lung procedures. the system is used for trajectory planning and is intended to assist the physician in the positioning of an instrument, such as a needle, where ct imaging is used for target trajectory planning and intraoperative tracking. this study will evaluate safety and accuracy of the xact ace robotic system in subjects undergoing ct guided, minimally invasive percutaneous procedures of the lung in the interventional radiology suite.

Eligibility criteria:
inclusion criteria: 1. 18 years of age 2. subjects undergoing ct-guided, minimally invasive percutaneous lung procedures in the interventional radiology suite, e.g., core biopsy, fine needle aspiration (fna), tumor ablation, etc. 3. following planning and registration ct scans, subject is found eligible to undergo ct-guided, minimally invasive percutaneous procedure 4. subject is willing to sign informed consent 5. subject is capable of adhering to study procedures exclusion criteria: 1. subjects in whom the target is within 1 cm of a major blood vessel, major nerve or heart 2. subject with significant coagulopathy 3. subject with preexisting or unstable medical condition(s), which in the opinion of the investigator, might interfere with the conduct of the study 4. subjects who are pregnant or nursing 5. following planning and registration ct scans, required clinical trajectory to target is beyond system workspace limits (e.g., entry angle is too sharp)
radiolabelled nectin-4 targeted lmw probe pet/ct in patients with lung lesions

Conditions: Lung Cancer, Non-Small Cell; Lung Infection

Summary: to evaluate the ability of \[68ga\]n188 to detect nectin-4 overexpression in patients with lung lesions.

to evaluate the ability of \[68ga\]n188 to detect nectin-4 overexpression in patients with different lung lesions, such as inflammation and lung cancer.

Eligibility criteria:
inclusion criteria: 1. 18-75 years old, male or female; 2. heart function is normal; 3. normal heart function; 4. estimated survival ≥12 weeks; 5. good follow-up compliance; 6. presence of at least one measurable target lesion according to recist1.1 criteria; 7. women of childbearing age (15-49 years) must have a negative pregnancy test within 7 days before starting the test; fertile men and women must agree to use effective contraception to prevent pregnancy during the study period and for 3 months after the test; 8. patients recommended by clinicians to undergo pet/ct examination for tumor diagnostic staging; 9. the subject patients could fully understand and voluntarily participate in the experiment, and signed the informed consent. exclusion criteria: 1. serious abnormality of liver, kidney and blood; 2. pregnant patients; 3. pregnant and lactation women; 3) unable to lie flat for half an hour; 4) refuse to join the clinical investigator; 5) suffering from claustrophobia or other mental diseases; 6) other conditions that researchers deem unsuitable for participating in the experiment.
study of at-527 in combination with daclatasvir in subjects with hepatitis c virus (hcv) infection

Conditions: Hepatitis C; Hepatitis C, Chronic; Chronic Hepatitis C; Hepatitis C Virus Infection; HCV Infection

Summary: the study will assess the safety and efficacy of at-527 in combination with daclatasvir after 8 or 12 weeks of treatment.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) of 18-35 kg/m2 * must agree to use protocol-specified methods of contraception * negative pregnancy test * hcv genotype 1 * documented history compatible with chronic hepatitis c * hcv rna ≥ 10,000 iu/ml at screening. * willing to comply with the study requirements and to provide written informed consent exclusion criteria: * pregnant or breastfeeding * infected with hepatitis b virus or hiv * abuse of alcohol or drugs * prior exposure to any hcv ns5a inhibitor * cirrhosis * use of other investigational drugs within 30 days of dosing * other clinically significant medical conditions or contraindications to daclatasvir
bone mineral density changes among clinical subtypes of parkinson's disease

Conditions: Parkinson Disease; Bone Loss

Summary: the bone loss in parkinson's disease (pd) emerges as a non-motor symptom with motor and non-motor outcomes, such as fracture and musculoskeletal pain. bone mineral density (bmd) is decreasing in patients with pd when compared to sex and age-matched healthy controls. the changes in bmd according to clinical subtypes of pd is unknown. the investigators are planning to compare the bmd status between the tremor dominant and postural instability and gait difficulty type of pd.

the investigators are planning to complete this study between january and february 2019. this study will be performed at ordu university education and research hospital, neurology department. all patients admitted to the outpatient clinic will be evaluated in terms of inclusion criteria. the control group consisted of people who do not have any orthopedic, neurological or metabolic disorders which may affect the bmd.

Eligibility criteria:
for tdt and pigdt pd group inclusion criteria: clinical diagnosis of idiopathic parkinson's disease age of 40-85 years exclusion criteria: having additional orthopedic and neurological disorders having metabolic disease, having steroid drug use for control group the similar age and sex-matched healthy individuals who have no orthopedic, metabolic and neurological disorders, and steroid use will be included in the study.

Keywords: bone mineral density parkinson's disease tremor postural instability and gait difficulty akinetic-rigid
safety and efficacy of spil1033 in subjects with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: spil1033 resembles a gut hormone, which increases the insulin secretion, thus helps in reducing blood glucose levels. the purpose of study is to establish safety and efficacy of spil1033

spil1033 is subcutaneous injection is indicated as adjunctive therapy to improve glycemic control in patients with type 2 diabetes mellitus. in this study, efficacy and safety of spil1033 will be evaluated. subjects will receive spil1033 or placebo, 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks.

Eligibility criteria:
inclusion criteria: * male and female subjects 20 years of age and older. * established clinical diagnosis of type 2 diabetes mellitus treated with diet and exercise or anti-diabetic agents as monotherapy or combination therapy. * weight stable: their weight should not have varied more than 10% of screening visit weight, within 6 months prior to screening visit. * women of child bearing potential practicing an acceptable method of birth control as judged by the investigator(s); with a negative urine pregnancy test. * willing to participate and give written informed consent. exclusion criteria: * previous exposure to exenatide (anti-exenatide antibodies at screening) or a glucagon-like peptide (glp-1) analogue. * used drugs for weight loss (for example, orlistat, sibutramine, phenylpropanolamine, rimonabant, or similar over-the-counter medications) within 3 months of screening. * received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of trial entry. * severe renal impairment (creatinine clearance \<30 ml/min) or end stage renal disease.

Keywords: spil1033 type 2 diabetes mellitus